Santen Pharmaceutical Co., Ltd. said the FDA has accepted the premarket approval (PMA) application for DE-128 (Microshunt) for review. DE-128 is an investigational surgical glaucoma implant designed to reduce IOP in patients with primary open-angle glaucoma whose IOP is not controlled when using maximum tolerated glaucoma medications. The device is composed of a synthetic polymer of poly(styrene-block-isobutylene-block-styrene). Similar to the Xen gel stent (Allergan), the Microshunt has a 70-µm lumen that aims to limit fluid outflow. The Microshunt is designed to be implanted in an ab externo fashion and also requires the use of MMC. The shunt has small tabs that are used to secure the device into a shallow scleral pocket, and it connects the anterior chamber to the sub-Tenon space.

The substantive review of the device, which traditionally spans 180 days from the FDA’s receipt of the PMA final module, is an in-depth review following which the FDA will make a decision as to whether the PMA is approved.